Balloon irrigation and cleaning system for interior walls of body cavities

ABSTRACT

A method and apparatus for cleansing the interior surfaces of body cavities employs a balloon catheter adapted to be inserted into a cavity through its ostium with the balloon in collapsed condition. An input flow tube for a cleansing and/or medicating fluid passes through a central passage in the balloon. When the balloon is inflated to establish a narrow passage between the balloon and the cavity walls, a pressurized flow of the fluid is pumped out the distal end of the input flow tube through the passage, parallel to the cavity walls, where it scours the inner wall of the cavity, removing debris as it flows out of the ostium. The fluid flow is urged toward a turbulent condition by attachments to the outer wall of the balloon.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/172,393, filed Feb. 4, 2014, now U.S. Pat. No. 10,758,667, whichclaims the benefit of U.S. Provisional Application 61/760,468 filed onFeb. 4, 2013, the entire content of both applications being incorporatedherein by reference.

FIELD OF THE INVENTION

This invention relates to a method and apparatus useful to clean, scrub,debride or irrigate, the interior surfaces of body cavities and moreparticularly to such a method and apparatus employing a balloon-likeinflatable catheter.

BACKGROUND OF THE INVENTION

Balloon catheters have been employed to provide treatment to relativelyinaccessible body cavities such as occluded blood vessels, nasalcavities, wounds, or paranasal sinuses and the like. In some cases,these balloons are used to introduce fluids onto the linings of variousbody cavities to carry medications such as antibiotics and the like intointimate contact with the interior surfaces of the cavities. Attempts toclean a cavity with a forceful jet into the cavity that is filled withfluid is defeated as its force is absorbed by the fluid. A device thatreduces the volume of the cavity to a thin rim over the entire surfacecan force the flow directly onto the walls and in a direction thatparallels the walls but without dissipation of the force and coveringthe entire surface. In essence this is the basic concept of thisinvention.

Certain of these balloons have been formed with walls of porousmaterials so that the fluids from the interior of the balloons will flowoutwardly against the body cavity interior surfaces to provide medicatedfluids or the like to those surfaces. U.S. Patent Publication2007/0129751 assigned to Acclarent, Inc. discloses a device for balloonsinusplasty which may employ a balloon with porous walls to deliverfluids to the interior walls of sinus cavities. The fluid flows from theinterior of the balloon are thus generally directed perpendicularly tothe interior surfaces of the body cavity and are sometimes pressurizedso that any medication contained in the fluid will forcefully impact theinterior walls of the cavity. These fluid streams can only clean areassimilar to the Cross-sections of the streams and schemes for moving thestreams over the side walls invariably leave some areas untouched orunder cleaned. Increasing the force of the streams impacting the wallsmay do harm to the walls.

In many medical situations it is desirable to remove dead cells and thelike which may have accumulated on the interior wall of a body cavity.For example, in a healthy nose mucus produced by the lining of theparanasal sinuses drains out of the sinus through the ostium, an openingconnecting the interior of the sinus cavity to the nasal passages,carrying cellular and bacterial debris with it. In conditions such assinusitis the mucus may be prevented from freely exiting the ostium andtends to accumulate the debris on the interior walls of the sinuscavities interfering with the normal functions and healing of thecavities. This mucosal congestion may result in microbial growth on thesurface which must be removed to restore the sinuses to their normalfunction.

SUMMARY OF THE INVENTION

The present invention is accordingly directed toward methods andapparatus to irrigate, with or without medication, to scrub, clean,and/or debride the interior surfaces of infected body cavities or bodycavities suffering from accumulations of dead cells, mucous, bacteriaaccumulations or the like to restore them to a healthy condition. Thisis preferably done by a fluid flow in a direction generally parallel tothe cavity wall to scrub the wall without imposing forces that may harmthe wall.

Very broadly the method and apparatus comprises a balloon which may beinserted in deflated condition through the ostium of the cavity to betreated and then inflated to produce restricted passages between thecomplementary walls of the balloon and body cavity. A pressurized fluidflow is then introduced into the area between one end of the balloon,preferably the distal end, considering the ostium end to be the proximalend. This fluid flow passes over the outer sides of the balloon throughthe restricted passage. At the other end of the balloon, preferably nearthe ostium, an outflow tube, which may be negatively pressurized, sucksout the fluid, as well as any debris picked up by the fluid flow overthe interior walls of the cavity, such as cellular debris and the like.In other embodiments the fluid flow out of the cavity may be under theforce of gravity and/or the pressure of the inflowing fluid. This fluidflow along the interior walls of the cavity has many advantages overdevices that direct the fluid flow perpendicularly against the walls.First, pointing a forceful stream at the inner wall of the cavity isinefficient. First, the stream pointed more or less perpendicular to thewall cleans only an area more or less the cross sectional area ofstream. Repeated movement of the stream, crisscrossing the inner surfacearea over and over again is problematic that the walls can be completelyscrubbed clean. Also in some cases the force of the stream impacting thewall may be increased to a point that the wall itself is injured. A flowof cleaning fluid that runs parallel to the wall is a far more thoroughand efficient means of scrubbing the interior wall of a cavity with agreater freedom to increase pressures without destroying the interiorwall.

Second, soon after liquid is forced into a cavity the cavity will filland the effect of the stream is dissipated by the inertia of the liquidin the cavity. To push a relatively thin stream into a filled cavity, nomatter how large the outflow, produces a languid flow across/parallel tothe cavity inner surface.

In one embodiment of the invention, which will be subsequently disclosedin detail the inflow tube passes through the center of the balloon andthe central passage through the balloon is sealed against the outer wallof the inflow tube, in the manner of a Foley Catheter. In thisembodiment, when the balloon is in a collapsed condition, it may beinserted through the ostium, into the cavity, by passing the inflow tubeinto the cavity. The output end of the inflow tube projects beyond oneend of the balloon. This arrangement resembles a Foley Catheter.

In another embodiment the balloon will have irregular projectionsextending from its outer surface which will contact the interior wallsof the cavity and create interrupted passages between the outer wall ofthe balloon and the interior wall of the cavity. Fluid, which may bemedicated, is then introduced through an inflow tube which extendsthrough the center of the balloon and terminates at the distal end ofthe cavity. Pressurized fluid flow is then passed through the inflowtube and directed by a nozzle at the end of the tube against adeflecting structure, preferably supported on the distal end of theballoon, which directs the flow from the tube into the passage betweenthe balloon exterior and the interior wall of the cavity.

The irregularities on the balloon prevent direct flow out of thesepassages and continually deflect the fluid stream laterally, parallel tothe cavity wall in such a way as to achieve turbulent or near turbulentconditions in the fluid. The flow will debride contaminating elements onthe interior wall of the cavity and carry them to the proximal end ofthe balloon and of the cavity where they are drawn through outflowtrues, preferably with an active suction pressure exerted on the tubes.

The balloon may have radically extending corrugations on its outersurface to aid in creating turbulence or near turbulence in the fluidflow.

In certain embodiments of the invention which will be subsequentlydisclosed in detail the cross sectional shape of the protuberances thatproject from the sides of the balloon will be such as to induceturbulence or near turbulence in the fluid flow. Turbulence is also afunction of the dimensions of the device and the viscosity and flow rateof the fluid. Turbulence will greatly aid the debriding action. Thesurface of the balloon may have dimples or indentations to affect flowtowards a turbulent nature.

In other embodiments of the invention the outer surface of the balloonwill carry a resilient deflecting cowling which will lie flat over theexterior of the balloon when it is collapsed over the inflow tube andwhen the balloon is inflated one end of the cowling will projectoutwardly toward the interior of the cavity at an angle toward theostium to aid the deflection of the flow through the cavity.

In one embodiment of the invention the exterior side of the balloonsupports a planar raceway which spirals toward the ostium end of thecavity when the balloon is inflated. This raceway forces the input fluidto traverse a longer path than it would if it could flow directly towardthe ostium end of the passage between the exterior of the balloon andthe interior wall of the cavity. This increases the flow rate of thefluid after it exits the input tube and improves the ablating forceagainst the cavity interior, as well as elongate the flow path toincrease the cleaning action.

In some embodiments of the invention a concave deflector is supportedabove the output end of the input flow tube so as to deflect the flowaround the sides of the balloon. This deflector may be supported on theflow tube by umbrella-like ribs which allow the deflector to fold alongthe sides of the outflow tube during insertion of the tube and thedeflated balloon through the ostium of the body cavity. Once in thecavity, the deflector may be opened up either by a spring mechanism orthe force of the outflow from the tube. Alternatively, the deflector maybe moved between its folded and unfolded position by the manipulation ofcords or the like which may be controlled from the exterior of thecavity. The deflector may have a number of holes in its surface to allowthe fluid flow to irrigate the area of the cavity wall covered by thedeflector.

In still another embodiment of the invention the walls of the balloonmay be formed with pores or of a porous material. In this embodiment theincoming fluid flow, or at least a portion of it, is directed to theinterior of the balloon so that it passes through the pores under theinflow pressure and irrigates the walls of the cavity and mayadditionally interact with the fluid flow between the cavity and balloonwalls to assist in the creation of turbulence in that fluid flow.

The fluid flow is preferably arranged so that it achieves turbulence, ornear turbulence which acts to scrub the interior walls of the bodycavity as the fluid flows through the channels between the opposed wallsof the balloon and the cavity. In the embodiments with protuberancesextending from the balloon toward the wall of the cavity, the shape andposition of these protuberances, as well as indentations of the balloonwall, may be such as to influence the flow toward turbulence.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects, advantages, and applications of the present inventionwill be made apparent by the following detailed description of preferredembodiments of the invention. The description makes reference to theaccompany drawings in which:

FIG. 1 is a cross-sectional view through the upper forward portion of ahuman skull illustrating a device formed in accordance with the presentinvention for irrigating a paranasal sinus of the person;

FIG. 2 is an enlarged cross section of a body cavity having its innerwall being irrigated by a first embodiment of a device formed inaccordance with the present invention;

FIG. 3 is a cross section through the device and cavity of FIG. 3 takenalong lines 4-4 of FIG. 3;

FIG. 4 is a cross-sectional view like FIG. 2, illustrating analternative embodiment of the invention which includes a deflectordisposed at the output end of an inflow tube in order to direct the flowthrough the passage between the exterior of the balloon and the interiorwall of the cavity;

FIG. 5 is a cross section through a body cavity employing an alternativeembodiment of the invention which comprises an extending canopy foraiding and directing the fluid flow against the interior walls of thecavity;

FIG. 6 is a similar cross-sectional view through an alternativeembodiment of the invention having a spiral canopy supported on itsexterior surface to accelerate the fluid flow and drive it against theinterior walls of the cavity; and

FIG. 7 is an enlarged cross section of one form of a protuberance formedon the balloon exterior.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

While the present description of the invention deals with the paranasalsinuses as the body cavities to be treated, it should be understood thatthe method and apparatus of the present invention have application toother body cavities and passages such as arteries, naso-lachrymal ducts,eustachian tubes, or the like and the present description should not beviewed as limited to the paranasal sinuses.

The paranasal sinuses are prime examples of the type of body cavitiesthat may be treated using the methods and apparatus of the presentinvention because they are lined with mucus-producing tissue whichnormally drains out of each sinus under gravity forces but in certaincases this drainage does not operate properly and the openings betweenthe sinuses and the connecting nasal passages may become blocked,leading to congestion of the sinuses and potential microbial growthwhich can produce a sinus infection. The mucosal linings of the cavitybecome contaminated with both live and dead bacteria and other debris.Removing this debris may be a first step in curing the infection.

Referring to FIG. 1, the method and apparatus of the present inventionis directed toward irrigating, for the purpose of debriding and cleaningthe interior surface of a body cavity such as a paranasal sinus 10.Essentially, the invention comprises a fluid inflow tube 12 whichcarries a balloon 18 which may be inserted into the cavity 10 throughits ostium while the balloon is in a deflated condition, and then airand/or fluid flow through the tube 12 inflates the balloon 18 to createa narrow passage between the exterior of the balloon and the interiorwall of the cavity. A fluid inflow through the tube 12 then exits theballoon as will be subsequently detailing and moves forcefully againstthe interior wall of the cavity to perform the cleaning and debridingoperation.

Referring to FIG. 2, which constitutes a cross section through theparanasal cavity 10, an instrument which practices the method of thepresent invention comprises an inflow or irrigation tube 12 which isadapted to pass through the ostium 14 of the cavity 10 so that a firstend of the irrigation tube is outside of the cavity and a second endterminates in an open end 16 of the tube which may be positioned nearthe distal end of the cavity 10 with respect to the ostium.

The tube 12 passes through a central cavity in a balloon 18 which isshown in inflated condition. The wall of the central cavity is securedto the outer wall of the tube 12 as in a Foley Catheter. The distal end16 of the tube 12 extends beyond the balloon 18 and the proximal end ofthe tube 12 extends through the ostium 14 to the exterior of the cavity.

An inflation tube 20 which is formed about the outer wall of the tube 12extends through the ostium and carries air from a pump 22 into theballoon 18, through side ports 24, in order to inflate the balloon afterit has been inserted into the cavity through the ostium. A second pump26 is connected to the inlet or irrigation tube 12 at the proximal end.It acts to pump fluid from any appropriate source (not shown) throughthe tube 12 and out the open distal end 16 at the far end of the cavity10. The output end 16 of the input tube 12 may be fitted with anappropriate nozzle, spray head, or the like (not shown) or it may simplybe left open in certain embodiments.

The flow from the output 16 of the tube 12 passes through the relativelynarrow passage 30 defined by the inner wall of the body cavity 10 andthe outer wall of the balloon 18. The flow extends downwardly in thedrawing of FIG. 2 until it reaches the area of the ostium which it maypass through by gravity and the force of the input flow, oralternatively exit the cavity 10 through a suction passage 32 which isevacuated by a pump 34.

Depending upon the inflow rate through the tube 16, the viscosity of thefluid being pumped through the tube, and physical dimensions of theapparatus, the fluid flow may achieve turbulence at various pointsduring its passage. The turbulence aids in scouring any debris from theinner wall of the body cavity 10. A nonturbulent or laminar flow willalso act to debride material from the inner wall of the cavity. Theballoon 18 may be inflated to a condition wherein its outer surface issomewhat flaccid and deforms under the fluid flow forces, which willassist in the creation of a turbulent flow in certain geometries.

A plurality of protuberances 34 spaced over the exterior of the balloonmay contact the inner walls of the cavity 10 to assist in spacing theouter surface of the balloon with respect to the inner wall of thecavity or, in alternative embodiments, the outer ends of the projections34 may be spaced from the inner wall of the cavity when the balloon isin its inflated condition.

The protuberances are spaced along the outer surface so that there is noclear path for the fluid to flow through the channel 30, but rather theprotuberances deflect the flow laterally, increase the speed of theflow, and in certain situations may bring the flow to a turbulent state.The cross sections of the protuberances 34 may be airfoil shaped or thelike, as shown in FIG. 7, to increase the speed of a flow over theirsurfaces and promote turbulence at their trailing edges.

At the far end of the flow path, adjacent to the ostium 14, the outputflow may be pressurized by the suction pump 36 or, in some embodiments,it may simply flow out of the ostium under gravity forces and/or thepressure of the incoming flow.

In use, the balloon 18 is initially deflated so that it lies closelyalong the exterior of the inflow tube 12 and may be inserted into thebody cavity 10 through the ostium 14, with the tube. The balloon maythen be inflated by air or other gas through the pump 22 and the tube20. The gas will flow outwardly into the interior of the balloon throughthe ports 24. The balloon 18 may be inflated until the extending edgesof the projections 34 contact the inner wall of the cavity 10 or, to alesser degree, allowing a larger free channel 30 for fluid flow. Fluidis then forced through the inflow tube 12 by the pump 26 and exits intothe channel 30 through the top 1.6 of the inflow tube 12. The fluid isforced through the channel 30 which surrounds the balloon and scours theinner walls of the cavity 10 to remove any loose material such as deadcells, accumulated mucus, and the like. This material is then carriedout the ostium through the fluid forces and gravity or alternativelythrough the channel 32 based on the vacuum created by the pump 36. Afterthe irrigation is completed, the balloon may be deflated by reversingthe pump 22 and then the inflow tube 12, with the collapsed balloondraped over its surface, may be withdrawn through the ostium 14.

FIG. 3 is a cross-sectional view through the embodiment of FIG. 2, takenalong line 4-4 of FIG. 2. The arrows illustrate the transverse patternof the fluid flow as a result of interference between the otherwisedownward flow toward the ostium, wherein the lateral movement is forcedby the interference between the flow and the projections 34.

FIG. 4 illustrates an alternative form of the invention which includes afoldable deflector 44 supported on the output end 16 of the inflow tube12. In this embodiment the same numbers are applied to the components tothe extent they are identical to the components of the embodiment ofFIG. 2.

The deflector is a thin, concave shell which extends to a form parallelto the inner wall 10 of the cavity, at the end of the cavity opposite tothe ostium. It may be formed of a flexible material. The deflector 44 issupported on the end 16 of the input tube by means of ribs 46 whichpreferably have one end pivotably attached to the end 16 of the inflowtube and their other ends pivotably attached to the shell 44 at spacedpoints. The deflector 44 may be moved to a collapsed form wherein itlies along the sides of the distal end of the tube 12 for insertion andremoval of the tube through the ostium. It preferably has a plurality ofholes 48 in its surface to allow the flow from the output of the tube 12to move against the inner wall of the cavity 10 on the convex side ofthe deflector. The deflector forces the flow from the output end 16 ofthe tube 12 along the sides of the balloon through the channel 30.

In the embodiment of FIG. 4 there are no projections 34 extending fromthe surface of the balloon, but the input flow rate is such as to forcethe flow against the inner wall 10 of the cavity at speeds which mayachieve turbulence to aid the scouring action. Since there are noprojections from the outside of the balloon, the balloon may be inflatedinto closer proximity to the wall 10 of the cavity than the embodimentof FIG. 2.

The deflector 44 may normally assume its collapsed condition about theexterior of the tube 12 through use of biasing means such as a spring(not shown). It may then be forced open by the flow out of the end 16 ofthe tube 12. Alternatively, it may normally be biased toward an extendedposition and cables or the like (not shown) may be passed through thetube 12 from the exterior of the cavity 10 to the deflector 44 to forceit into a folded condition.

FIG. 5 illustrates another embodiment of the invention, much like theembodiment of FIG. 3, but further including a canopy 50 which has oneend 52 attached to the exterior of the balloon and the other end free ofthe balloon. The canopy 50 may be normally biased so as to lie over thesurface of the balloon 18 for insertion and removal of the apparatusthrough the ostium 14. Once in the cavity, and after the balloon isinflated through the tube 20, the lower end 54 of the canopy 50 may beshaped to extend outwardly toward the side walls of the cavity and forcethe fluid flow against the side walls 10 of the cavity. By narrowing theresulting passage between the exterior of the balloon and the interiorof the cavity, the flow is accelerated and may attain turbulence atcertain points of its path.

FIG. 6 discloses another embodiment of the invention, similar to theembodiment of FIG. 5, with the exception that instead of having a singlecanopy 50 encircling the balloon, as illustrated in FIG. 5, a spiralcanopy 60 extends along the entire height of the balloon 18. The outputflow from the deflector 44 is directed against the top section of thespiral canopy 60 and the edges of the canopy 60 extend close to theinner walls of the cavity 10. The flow is forced to follow the spiralpath created by the canopy 60 and the fluid flow forces the flow toattain a high speed along the spiral path, heightening the ability toachieve turbulence in the flow.

Alternatively, the canopy 60 could take the form of separate closedrings extending around the perimeter of the balloon 18, rather than aclosed spiral track 60. These rings would create a corrugated patternthat would force the flow through the channel 12 to move back and forth,laterally while still moving from the outlet 16 to the ostium,increasing the scouring action.

The protuberances 34 illustrated in the embodiments of FIG. 2 and FIG. 4may be used in any of the embodiments and may be arranged in the shapeof an airfoil, as illustrated in FIG. 7 at 80, to enhance the turbulenceof the fluid.

1. A device for irrigating the interior surface of a body cavity, comprising: an inflatable balloon having an outer surface that is spaced apart from the interior wall of the body cavity when the balloon is inflated, such that a passage is formed between the outer surface of the balloon and the interior wall of the body cavity; a tubular structure having a distal end to which the inflatable balloon is coupled, the tubular structure including a first channel for inflating the balloon, a second channel for delivering a fluid to the passage, and a third channel for removing fluid from the passage; and wherein the fluid flows through the passage in a turbulent or near-turbulent condition.
 2. The device of claim 1, wherein the outer surface of the balloon contains a series of projections adapted to contact the interior wall of the body cavity when the balloon is inflated, such that the passage is obstructed by the projections, thereby forcing the fluid to flow in transverse directions.
 3. The device of claim 2, wherein the projections are irregularly spaced apart protuberances.
 4. The device of claim 2, wherein the projections are airfoil-shaped.
 5. The device of claim 1, wherein the first channel is used to inflate and deflate the balloon.
 6. The device of claim 1, wherein a positive pressure is applied to the fluid delivered to the second channel.
 7. The device of claim 1, wherein a negative pressure is applied to the fluid removed from the third channel.
 8. The device of claim 1, wherein the second channel passes through the balloon and the fluid exits into the passage at the distal end of the balloon.
 9. The device of claim 1, wherein the second channel passes through the balloon, and the fluid exits into the passage at the distal end of the balloon.
 10. The device of claim 9, further including a canopy supported at the distal end of the balloon that extends outwardly causing the fluid flow to move against the inner wall of the cavity.
 11. The device of claim 9, further including a deflector supported at the distal end of the balloon having a plurality of holes causing the fluid flow to move against the inner wall of the cavity.
 12. The device of claim 1, wherein the balloon in its inflated condition is flaccid and ripples under the force of the inflow fluid to induce the fluid motion toward turbulence.
 13. The device of claim 1, wherein the input flow rate is such as to force the flow against the inner wall of the cavity at speeds to induce the fluid motion toward turbulence.
 14. The device of claim 1, wherein the outer surface of the balloon defines a spiral track when inflated.
 15. The device of claim 1, wherein the balloon is formed with pores or of a porous material such that at least a portion of the the incoming fluid flow is directed to the interior of the balloon so that it passes through the balloon and interacts with the fluid flow between the cavity and balloon walls to induce the fluid motion toward turbulence.
 16. The device of claim 1, wherein the turbulent fluid flow is operative to debride the interior wall of the cavity.
 17. The device of claim 1, wherein the fluid contains a medication which is applied to the interior wall of the body cavity. 